K101345 is an FDA 510(k) clearance for the WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,. This device is classified as a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II - Special Controls, product code DRF).
Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on June 22, 2010, 40 days after receiving the submission on May 13, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K101345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2010 |
| Decision Date | June 22, 2010 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |